Pre-Submission (Q-Sub) package
One shot at the meeting with CDRH. We make it count. Briefing book, FDA-style draft answers, and a mock session, grounded in predicate precedent and recent device correspondence in your category.
A bad Q-Sub adds 6 months to your filing
Q-Sub is the cheapest way to get FDA's view on your pathway, predicate strategy, performance testing plan, and clinical evidence approach. Done well, it shaves months off your 510(k) or De Novo. Done poorly, it confirms what you already knew and leaves you guessing on the controversial issues.
Most sponsors ask the wrong questions or ask them the wrong way. CDRH responds to specifics, not generalities. We make sure every question is binary, defensible, and has the precedent to back it up.
A complete Q-Sub package, ready for submission
Q-Sub request letter and meeting agenda
CDRH-formatted, with proposed agenda, attendee list, and product context.
Briefing document with predicate analysis
30–60 pages. Predicate device benchmarking, performance testing strategy, clinical evidence framing, and the precedent that supports your position.
Question framing & FDA-style draft answers
3–6 binary, actionable questions with our anticipated CDRH response and the rationale.
Mock meeting & coaching
2-hour mock with our senior regulatory specialist playing CDRH. Live coaching on tone, what to concede, what to defend.
Test the relationship, or commit to the full package
Pick the on-ramp that fits your milestone and signing authority. Both come with a fixed-fee SOW in 24 hours.
Q-Sub scoping memo
A focused regulatory brief to validate your Q-Sub direction and pathway choice before committing to a full package.
- 15–20 page strategic brief
- Pathway recommendation: 510(k), De Novo, or PMA
- 2 questions framed CDRH-style with anticipated answers
- 1-hour readout call with regulatory specialist
Full Q-Sub package
Everything you need for a productive CDRH meeting, end to end.
- Full briefing document (30–60 pages)
- 3–6 fully framed questions and CDRH-style draft answers
- Q-Sub request letter, formatted and submission-ready
- 2-hour mock meeting and live coaching
Q-Sub meeting in the next quarter?
Send a note about your device and intended pathway. You'll get a fixed-fee proposal back within one business day, with timeline, fee, and proposed staffing.